Special Populations: Reduce maintenance dose in patients with cor
pulmonale, heart failure or liver and in elderly. Increase
maintenance dose for smokers.

Incompatibility: Incompatible with metals.

Contraindications:
Aminophylline injection should not be used in patients
hypersensitive to ethylenediamine or those allergic to the
theophyllines, caffeine or theobromine.

Aminophylline should not be administered concomitantly with other
xanthine drugs. When therapeutic doses of Aminophylline and/or
theophylline are administered simultaneously by more than one route
or in more than one preparation, the hazard of serious toxicity is
increased.

The use of Aminophylline IV in children under 6 months of age is
not generally recommended.

The use of Aminophylline is contra-indicated in patients with acute
porphyria.

Overdosage:
Symptoms may include agitated maniacal behavior, frequent vomiting,
extreme thirst, slight fever, tinnitus, palpitation and arrhythmias.
Treatment is usually supportive and withdrawal of the drug.
Restoration of fluid and electrolyte balance is necessary.

Pregnancy & Lactation:
Category C: Either studies in animals have revealed adverse effects
on the foetus (teratogenic or embryocidal or other) and there are no
controlled studies in women or studies in women and animals are not
available. Drugs should be given only if the potential benefit
justifies the potential risk to the foetus.

Pharmacology:
It inhibits the synthesis of prostaglandins D and E resulting in
analgesic, anti-inflammatory and antipyretic effects. It also has
the potential for causing agranulocytosis.
Absorption: Rapidly hydrolysed in gastric juice to active
metabolite 4-methyl-amino-antipyrine.
Distribution: Metabolites are distributed into breast milk.
Excretion: Mostly excreted in the urine as metabolites.Indications:
As an Analgesic /Dipyrone Injection, by intravenous
administration, is indicated for the relief of severeand acute pain
when oral treatment is not feasible or suitable, as in
post-traumatic orpost-surgical pain, biliary or renal colic, and
pain associated with malignant s.Intravenous administration
of dipyrone should be carried out slowly over a period ofat least 5
minutes, followed by reasonable clinical observation. Intramuscular
administration of dipyrone for relief of pain is not recommended.
However, if medical circumstances require such administration, all
due precautions should be exercised to permit reasonable clinical
observation. As an Antipyretic /Dipyrone Injection, by
intramuscular administration, is indicated to lower temperature in
life-threatening situations, when this cannot be achieved by other
means. patients in critical condition may also be treated in
non-hospital environment, under close medical supervision.

Dosage & administration:
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration,
whenever solution and container permit. Adults and Adolescents Over
14 Years of Age Intravenous Administration as an Analgesic 1 g (2
ml), administered by slow injection, up to 4 times daily. In severe
pain, 2.5 g (5 ml) may be administered twice daily (the maximum
daily dosage is 5 g).Intramuscular Administration as an
Antipyretic2.5 g (5 ml), to be repeated only if deemed necessary.
Infants and Children Use of dipyrone is not recommended in infants
under 3 months of age or5 kg/body weight. In infants 3-12 months,
/Dipyrone Injection should be administered by the
intramuscular route only. In older children, the injection may be
administered by eitherthe intramuscular or intravenous routes.
Dosage guidelines for the administration of /Dipyrone
Injection as an analgesic and/or antipyretic, in infants over 3
months of age and in children, are presented in the table below:

Age

Smallest

Maximum

Single Dosage

Daily Dosage

3-5 months

0.1 ml I.M. only

4 x 0.2 ml

6-11 months

0.1 ml I.M. only

4 x 0.3 ml

1-2 years

0.2 ml I.M./I.V.

4 x 0.4 ml

3-4 years

0.2 ml I.M./I.V.

4 x 0.6 ml

5-7 years

0.4 ml I.M./I.V.

4 x 0.8 ml

8-11 years

0.5 ml I.M./I.V.

4 x 1.0 ml

12-14 years

0.8 ml I M/ I.V.

4 x 1.6 ml

Contraindications:
Known hypersensitivity to dipyrone or to pyrazolone derivatives or
to any other ingredient of the preparation. Pregnancy and
breastfeeding. Acute porphyria. Genetic deficiency of the enzyme
glucose-6-phosphate dehydrogenase (G6PD). History of blood
dyscrasias or acute bone marrow suppression

Interactions:
Dipyrone/ : Concurrent use of dipyrone and
may cause hypothermia; therefore combined therapy
with these two drugs should be avoided. Dipyrone/Cyclosporin:
Dipyrone may cause a reduction in cyclosporin blood levels, byan
unknown mechanism.

Dipyrone/ Alcohol: Concurrent administration is not recommended in
patients who react to small quantities of
(flush, lacrimation and sneezing), since these patients may be more
prone to allergic reactions to dipyrone. Dipyrone/Anticoagulants:
Because of possible thrombocytopenia appearing as an adverse
reaction of dipyrone, caution is required when dipyrone is
administered to patients on anticoagulant therapy.

Precautions:
Careful inquiry should be made concerning previous hypersensitivity
reactions of the patients to drugs and food. Red coloration may
appear in urine with acid pH; it may be due to an exceedingly small
quantity of a metabolite (rubazonic acid).
Caution should be exercised when dipyrone is used in patients with
hepatic or renal disorders

Warning:
When using parenteral dipyrone, special consideration should be
given to thepossible risk of life-threatening complications
resulting from "shock syndrome".It should be remembered
that the risk of shock is much greater with parenteraladministration
than with oral administration.
Careful monitoring is warranted in patients with high fever. Rare
cases of agranulocytosis, as a hypersensitivity reaction, have been
reported. The appearance of symptoms indicative of agranulocytosis,
such as high fever, pain in throat, buccal ulceration, tiredness,
and weakness, warrants immediate discontinuation of the drug, and an
urgent blood count determination. Special caution is required in
patients who may be more prone to hypersensitivity reactions, as in
patients with bronchial asthma and chronic urticaria. As with other
pyrazolone derivatives, cutaneous allergic reactions may appear
suchas urticaria and maculopapular eruption. Exceptionally, they may
be severe enoughand manifested by epidermal necrolysis (Stevens
-Johnson syndrome or Lyell'ssyndrome), in which case immediate
discontinuation of treatment is imperative. /Dipyrone
Injection contains sodium dithionite as an antioxidant preservative.
As withother sulfites, sodium dithionite may cause allergic-type
reactions in certain susceptible patients, including anaphylactic
symptoms and life-threatening, or less severe, asthmatic episodes.
The overall prevalence of sulfite sensitivity in the general
population is unknown and probably low. Sulfite sensitivity is seen
more frequently in asthmatic than in nonasthmatic patients.

Side Effects:
The most serious adverse reactions to dipyrone are "shock
syndrome", andagranulocytosis (see also Warnings). Allergic
Anaphylactic shock (see Warnings). Agranulocytosis has rarely been
reported. It is an immuno-allergic adverse reaction lasting at least
1 week. Agranulocytosis is unpredictable, not dose-related and may
occur even after a single dose. Dermatological reactions (see
Warnings).Hematological Rarely agranulocytosis, anemia, leucopenia
and thrombocytopenia, have been reported. Renal Isolated cases of
acute renal insufficiency or interstitial nephropathy have been
reported. Other Drowsiness, tiredness, and headache have been
reported with dipyroneadministration. Hypotension has been reported
following intravenous administration of dipyrone. Nausea, vomiting,
gastric irritation and xerostomia have been described with oral and
parenteral dipyrone administration

Pregnancy & Lactation:
Read Contraindications

Storage:
Store below 25°C

Packing presentations:
(Also can be packed according to customers requirement)
Ampoule of 2 ml/ vial of 30 ml